Saving Life and Limb: FES for the Elderly With PAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will take the first step to improve public health for millions of Americans with Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The investigators will assess a proof of concept, home administered, functional electrical stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation

NCT01548508

Chronic Heart Failure

COMPLETED NA

Functional Electrical Stimulation in Cardiac Patients

NCT02088138

Coronary Disease Heart Failure

COMPLETED NA

Effect of Transcutaneous Electrical Nerve Stimulation in Peripheral Artery Disease TENS-PAD Study / TENS-AOMI

NCT02678403

Peripheral Artery Disease

TERMINATED NA

Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients

NCT03795103

Arteriopathy

COMPLETED NA

Effect of Lower Leg Heating and Transcutaneous Electrical Nerve Stimulation on Exercise Capacity in Patients With PAD

NCT03462472

Peripheral Arterial Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will evaluate an innovative approach to reduce the debilitating symptoms of peripheral arterial disease (PAD) and ischemic pain during walking (intermittent claudication) by using a new Functional Electrical Stimulation (FES) system. The investigators hypothesize that combining the FES and walking one hour/day (FES+Walk) will significantly reduce pain during walking, improve locomotion, and enhance quality of life when compared to walking one hour/day (Walk) alone after 8 weeks of intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Walk Group

This group of patients are part of the walk group. They will be encouraged to walk and will receive standard care, defined as conservative (non-surgical) management of signs and symptoms, including prescriptive medications to improve circulation and manage pain, determined by their attending physician on a case by case basis.

Group Type NO_INTERVENTION

No interventions assigned to this group

FES + Walk Group

This group of patients will participate in Functional Electrical Stimulation (FES) and exercise. This group will receive functional electrical stimulation as an intervention. The FES device will stimulate (activate) the calf and shin leg muscles of both legs while the patient is walking. This group will also receive standard care, defined as conservative (non-surgical) management of signs and symptoms, including prescriptive medications to improve circulation and manage pain, determined by their attending physician on a case by case basis.

Group Type EXPERIMENTAL

FES (Gait MyoElectric Stimulator)

Intervention Type DEVICE

Functional Electrical Stimulation (FES) will be tested in a group of peripheral arterial disease patients using the Gait MyoElectric Stimulator. The FES device will be applied to the calf and shin muscles on both of the patients legs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FES (Gait MyoElectric Stimulator)

Functional Electrical Stimulation (FES) will be tested in a group of peripheral arterial disease patients using the Gait MyoElectric Stimulator. The FES device will be applied to the calf and shin muscles on both of the patients legs.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients who:

1. Are ambulatory, community dwelling adults with evidence of PAD including ankle/brachial index ABI=0.4-0.9
2. Have symptom severity of Fontaine stage II-III
3. Have a score of 24 or higher on the Folstein Mini Mental test
4. Have visible muscle contraction of the plantar flexor (PF) and dorsiflexor (DF) muscles using FES

Exclusion Criteria

Patients who:

1. Have an electronic implanted stimulator such as pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator
2. Are pregnant
3. Cannot walk without a walker or require human assistance to walk,
4. Present with arthritis or neurological damage resulting in paresis or paralysis of the lower extremity
5. Have skin lesion(s) on the legs where the FES is placed

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No